Medical Device Registration in
Maldives
Ministry of Health:
Regulatory Authority:
Maldives Food and Drug Authority
Medical Device Regulation:
The Maldives does not have a defined regulation for medical devices. It does accept medicinal products regulated by major global regulatory authorities, along with few more supporting documents.
Official Language:
Maldivian, English, Arabic
Classification:
Not Defined
Medical Device Registration in Maldives:
- Appoint an Authorized Representative
- Prepare the application form and required documents for Medical Device Import License.
- AR submits the application to the regulatory authority
- Once Import License is issued, the medical device can be marketed in the Maldives.
Documents Required:
- Application Form
- LoA for Authorized Representative
- Manufacturer Information
- Product Information
- Previous regulatory approvals
- Conformity Assessment certificate by a Notified Body
- Declaration of Conformity
- CE mark
Applicable QMS:
ISO 13485
Authorized Representative:
Yes
Special Notes:
Product samples may be asked at the time of application.